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Laser medicine / Yttrium aluminium garnet / Nd:YAG laser / Laser / Er:YAG laser / Port-wine stain / Ablation / Light-emitting diode / Medicine / Optics / Optical materials


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Document Date: 2011-08-29 00:29:18


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File Size: 233,49 KB

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City

Ljubljana / /

Company

K101306 Trade / Fotona d.d. / /

Country

Slovenia / /

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Event

FDA Phase / /

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IndustryTerm

similar clinical applications / energy source / chemical composition / announcements concerning your device / predicate devices / manufacturing practice requirements / marketed predicate devices / manufacturing practice / cleared devices / laser technology / Internet address / power supply technology / laser energy / energy / /

OperatingSystem

XP / /

Organization

Orthopedic And Restorative Devices Office / Division of Postmarket Surveillance / N. Melkerson Director Division of Surgical / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / CDRH's office of Surveillance / 4L Division of Surgical / /

Person

Silver Spring / Stojan Tro / Stegne / Wavelength Fotona Fidelis III / Stojan Trogt / /

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Position

Manager Phone / Regulatory Affairs Manager / General / /

Product

Federal Food / ReCeiVed7 / /

ProvinceOrState

Maryland / /

Technology

radiation / Laser / power supply technology / lasers / laser technology / http / optical fiber / flash / Laser System / /

URL

www.fda.gov/MedicalDevices/Safety/ReportaPioblem/~defaulthtm / www.fda / /

SocialTag